- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00679237
Risk Reduction in Coronary Heart Disease (SPREK!)
March 16, 2021 updated by: Sissel Ledang, Sorlandet Hospital HF
Risk Reduction in Coronary Heart Disease - a Prospective Randomized Study
Study hypothesis: Multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Arendal, Norway
- Sorlandet hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- acute myocardial infarction, CABG or PCI
Exclusion Criteria:
- Age < 18 and age > 80
- pregnant
- critical illness
- drug abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
no intervention
|
|
Active Comparator: Multifactorial intervention
Smoking cessation betablocker, diuretics, ACEI, ARB, statins, ezetimibe training influenza vaccine weight reduction metformin, glimepiride, insulin
|
NRT and varenicline
blood pressure control according to ESC guidelines
Cholesterol reduction according to ESC guidelines
daily walking
vaccine (FLuarix, Influvac etc)
s.glucose control according to ESC guidelines
diet tips
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
New cardiovascular events (MACE)
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Serena Tonstad, dr.med., Ullevaal University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2007
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
July 5, 2007
First Submitted That Met QC Criteria
May 14, 2008
First Posted (Estimate)
May 16, 2008
Study Record Updates
Last Update Posted (Actual)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 16, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antimetabolites
- Immunosuppressive Agents
- Immunologic Factors
- Natriuretic Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Metformin
- Glimepiride
- Diuretics
- Ezetimibe
Other Study ID Numbers
- S-07041a (REK)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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